510(k) K781489
- Device
- ACID PHOSPHATASE DIAG. KIT
- Applicant
- SCLAVO, INC.
- 510(k) number
- K781489
- Product code
- CJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-10-03
- Date received
- 1978-08-28
- Regulation
- 862.1020
- Classification name
- Acid Phosphatase, Nitrophenylphosphate
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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